Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Official Title

A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Keywords

Warm Antibody Autoimmune Hemolytic Anemia Warm antibody autoimmune hemolytic anemia (AIHA) Anemia Hemolysis Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Antibodies Immunoglobulins Autoantibodies Fostamatinib 150 mg bid Fostamatinib 150 mg

Eligibility

You can join if…

Open to people ages 18 years and up

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

  • Must have failed at least 1 prior treatment regimen for AIHA.

You CAN'T join if...

  • Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
  • Subject with a platelet count of < 30,000/μL.
  • Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
  • Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.

Locations

  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • Loma Linda University Cancer Center
    Loma Linda California 92350 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Rigel Pharmaceuticals
Links
www.aihastudy.com
ID
NCT02612558
Phase
Phase 2
Study Type
Interventional
Last Updated